An interventional study of FOCuSEd Integrated Intervention and Enhanced Usual Care in Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea and Overweight and Obesity, sponsored by Seattle Institute for Biomedical and Clinical Research. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Not applicable, Interventional, and Treatment
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 400 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.
Other: FOCuSEd Integrated Intervention
For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs.
Other: Enhanced Usual Care
Participants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of ≥ 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.
Participants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider.
The SF-12 PCS
The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 1 year
PROMIS Sleep-related impairment
The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
Time frame: 1 year
PROMIS Sleep-related impairment
The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
Time frame: 3 months
SF-12 PCS
The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 3 months
SF-12 MCS
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 3 months
SF-12 MCS
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 1 year
PROMIS Sleep Disturbance
The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
Time frame: 3 months
PROMIS Sleep Disturbance
The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
Time frame: 1 year
COPD exacerbation or death
Proportion of patients with COPD exacerbation or Death (composite outcome) \[ Time Frame: 3 months after randomization \]
Time frame: 3 months
COPD exacerbation or death
Proportion of patients with COPD exacerbation or Death (composite outcome) \[ Time Frame: 12 months after randomization \]
Time frame: 1 year
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
Time frame: 3 months
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
Time frame: 1 year
Weight Loss
Total (kg)
Time frame: 3 months
Weight Loss
Total (kg)
Time frame: 1 year
Clinically Significant Weight Loss
5% weight loss met
Time frame: 3 months
Clinically Significant Weight Loss
5% weight loss met
Time frame: 1 year
Cardiovascular risk score
Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Time frame: 3 months
Cardiovascular risk score
Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Time frame: 1 year
Social Support
Social Support for diet and exercise scales
Time frame: 3 months
Social Support
Social Support for diet and exercise scales
Time frame: 1 year
Depression
PHQ-8 Depression scale
Time frame: 3 months
Depression
PHQ-8 Depression scale
Time frame: 1 year
Strength and endurance
30 second chair stand
Time frame: 3 months
Strength and endurance
30 second chair stand
Time frame: 1 year
OSA Severity
Home-Sleep Apnea Testing: Respiratory Event Index
Time frame: 1 Year
Plan to share: Yes — We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: data will be available after 2029 for at least 6 years.
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jul 2028, 47 months after the start.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 47 months is above that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Pulmonary Disease, Chronic Obstructive →
Seattle Institute for Biomedical and Clinical Research